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SX-682 + Nivolumab for Pancreatic Cancer

DM
Overseen byDaniel Mulkerin, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Rochester
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use other investigational drugs, medications at immunosuppressive doses, or certain botanical preparations within 28 days before starting the study drug. It's best to discuss your current medications with the study team.

What data supports the idea that SX-682 + Nivolumab for Pancreatic Cancer is an effective treatment?

The available research does not provide specific data on the effectiveness of SX-682 + Nivolumab for Pancreatic Cancer. Instead, it focuses on the use of Nivolumab for other types of cancer, such as non-small cell lung cancer and melanoma. In these cases, Nivolumab has shown to improve survival rates and is better tolerated compared to some other treatments. However, without specific data on pancreatic cancer, we cannot conclude its effectiveness for this condition.12345

What safety data exists for SX-682 + Nivolumab in pancreatic cancer treatment?

The safety data for Nivolumab, a PD-1 inhibitor, includes reports of immune-related adverse events (irAEs) such as pancreatitis, colitis, and other immune-related toxicities. These adverse events have been observed in various cancer treatments involving Nivolumab, either alone or in combination with other drugs like ipilimumab. The management of these irAEs often involves corticosteroids or other immunosuppressive treatments like infliximab. However, specific safety data for the combination of SX-682 and Nivolumab in pancreatic cancer is not detailed in the provided research.678910

Is the treatment SX-682 + Nivolumab a promising treatment for pancreatic cancer?

Yes, the treatment SX-682 + Nivolumab is promising for pancreatic cancer because it shows potential in increasing the number of active immune cells that can fight the cancer, and it has been well-tolerated in trials. This suggests it could help improve survival rates, although more research is needed to confirm these benefits.1112131415

Research Team

DM

Daniel Mulkerin, MD

Principal Investigator

University of Rochester Wilmot Cancer Center

Eligibility Criteria

This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma who've completed at least 16 weeks of first-line chemo without the cancer getting worse. They must be able to perform daily activities (ECOG status 0 or 1) and not have brain metastases, active pneumonitis, recent major surgery, other cancers in the last three years, or use immunosuppressants. Participants need functioning organs and can't be pregnant or breastfeeding.

Inclusion Criteria

Patient must consent for baseline and on treatment biopsies
Subjects must have the nature of the study explained to them
After signing the ICF and HIPAA Authorization, subjects will be evaluated for study eligibility during the Screening Period (no more than 28 days before study drug administration) according to the following further inclusion/exclusion criteria
See 13 more

Exclusion Criteria

I have heart disease that limits my daily activities.
You have had a serious allergic reaction to a specific type of medication called a monoclonal antibody in the past.
Your EKG shows that your heart's QTc interval is longer than 470 milliseconds.
See 25 more

Treatment Details

Interventions

  • Nivolumab (Checkpoint Inhibitor)
  • SX-682 (Chemokine Receptor Antagonist)
Trial OverviewThe study tests SX-682 combined with Nivolumab as a maintenance therapy to find the highest dose patients can tolerate. It's for those whose disease didn't progress after initial chemotherapy. The goal is to see how well they handle this combination treatment and what effects it has on their cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental: SX-682 and NivolumabExperimental Treatment2 Interventions
SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+
Kevin Koch profile image

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker profile image

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

Syntrix Biosystems, Inc.

Industry Sponsor

Trials
14
Recruited
810+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Nivolumab (Opdivo) significantly improves overall survival and response rates in previously-treated patients with advanced nonsquamous non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CheckMate 057 trial.
Nivolumab has a manageable adverse event profile and is better tolerated than docetaxel, making it a valuable treatment option for patients who have progressed after chemotherapy.
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer.Keating, GM.[2018]
Nivolumab, an anti-PD-1 antibody, was administered to a 63-year-old female patient with metastatic melanoma after renal transplantation, highlighting the potential for anti-tumor activity in high-risk patients, despite the challenges of concurrent immunosuppression.
The patient experienced acute renal allograft rejection and renal failure shortly after starting nivolumab, indicating significant risks associated with this treatment in transplant recipients, but she later showed a positive clinical response after re-challenging with nivolumab while on hemodialysis.
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection.Ong, M., Ibrahim, AM., Bourassa-Blanchette, S., et al.[2023]
Nivolumab, an immune checkpoint inhibitor, significantly improves overall survival and progression-free survival in patients with advanced stage squamous cell non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CHECKMATE 017 study.
The safety and tolerability of nivolumab are favorable, and interestingly, the expression of the PD-L1 ligand does not predict treatment outcomes, suggesting that other factors may influence the effectiveness of this therapy.
Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence.Lim, JS., Soo, RA.[2018]

References

Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. [2018]
Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable. [2022]
5.Georgia (Republic)pubmed.ncbi.nlm.nih.gov
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. [2021]
The Simultaneous Onset of Pancreatitis and Colitis as Immune-related Adverse Events in a Patient Receiving Nivolumab Treatment for Renal Cell Carcinoma. [2022]
Risk of immune-related adverse events associated with ipilimumab-plus-nivolumab and nivolumab therapy in cancer patients. [2022]
Stuttering as a signal of encephalopathy associated with toripalimab in a pancreatic ductal adenocarcinoma patient: a case report. [2023]
Toxicity profile of approved anti-PD-1 monoclonal antibodies in solid tumors: a systematic review and meta-analysis of randomized clinical trials. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment of Immune Checkpoint Inhibitor Induced Colitis with Infliximab. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Randomized Phase II Study of Nivolumab With or Without Ipilimumab Combined With Stereotactic Body Radiotherapy for Refractory Metastatic Pancreatic Cancer (CheckPAC). [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Case Report: Nivolumab-Induced Autoimmune Pancreatitis. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial. [2023]
CD137 agonist-based combination immunotherapy enhances activated, effector memory T cells and prolongs survival in pancreatic adenocarcinoma. [2022]
A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. [2023]